Manufacturing Calibrations Specialist I

Catalent - Greenville, NC

Full-time - Entry Level

Greenville, NC

10,001+ employees

Chemical Manufacturing

About the position

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. This position performs calibrations on site pharmaceutical manufacturing equipment used to manufacture oral solid dosage products. The working hours for this position are from 8:00 am to 5:00 pm, Monday through Friday, with a 30-minute unpaid lunch break. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. As a Manufacturing Calibrations Specialist I, you will be responsible for performing equipment preventive maintenance and calibration procedures, compiling and maintaining all information and documentation relevant to all work in accordance with FDA guidelines, and working with manufacturing operators to schedule calibrations. You will also coordinate repairs and installations with facilities staff, contractors, and users to minimize interruptions, partner with manufacturing staff, users, and vendors to continuously improve operations, and work from standard operating procedures. Additionally, you will enter and track calibrations in the BMRAM database and perform all other duties as assigned.

Responsibilities

• Perform equipment preventive maintenance and calibration procedures.
• Compile and maintain all information and documentation relevant to all work in accordance with FDA guidelines.
• Work with manufacturing operators to schedule calibrations.
• Coordinate repairs/installations with facilities staff, contractors, and users to minimize interruptions.
• Partner with manufacturing staff, users, and vendors to continuously improve operations.
• Work from standard operating procedures.
• Enter and track calibrations in BMRAM database.
• Perform all other duties as assigned.

Requirements

• High school diploma required; Associate degree in technical or life sciences discipline preferred.
• 2+ years of pharmaceutical experience is required.
• 3+ years of manufacturing calibration experience preferred.
• Blue Mountain Regulatory Asset Manager experience preferred.
• Good understanding of cGMPs, industry and regulatory standards and guidelines.
• Good understanding of federal and local regulations regarding health and safety within manufacturing and packaging environments.

Nice-to-haves

• Experience with Blue Mountain Regulatory Asset Manager.
• Knowledge of additional regulatory compliance standards.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement savings plan with company match.
• 152 hours of PTO + 8 paid holidays.
• Opportunities for career advancement.
• Fast-paced, dynamic environment.